drugset / Trial / NCT03423680
A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
RandomizedParallel-groupDouble-blindTreatment
Summary
This is an 8-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood stabilizer for the treatment of patients (outpatients or inpatients) with type I or II bipolar disorder accompanied by major depressive episode, without any psychotropic features. This study involves patients who are considered by the investigator not to have a proper improvement, despite receiving a mood stabilizer (lithium or valproic acid) for a sufficient (≥ 28 days) period of time during the current depressive episode.
Timeline
- Start
- 2018-02-22
- Primary completion
- 2025-11
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aripiprazole | Other / unclassified | 2 mg | Oral |
| Subject | Aripiprazole | Other / unclassified | 5 mg | Oral |
| Subject | Aripiprazole | Other / unclassified | 10 mg | Oral |
| Subject | Aripiprazole | Other / unclassified | 15 mg | Oral |